Psoriasin Gel
NDC Package 52389-166-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Psoriasin Gel (coal tar topical gel) gel is read all package directions and warnings before use.Use only as directed.Apply (gently massage in) a small amount of Psoriasin Gel to affected areas.Apply one to four times daily or as directed by a doctor.Apply to thoroughly dry skin.The active ingredient, coal tar, in Psoriasin Gel may affect very light hair color; test first on a few strands of hair before broader application to areas where light colored hair is present.Wash affected area at least daily with mild soap and warm water and dry thoroughly.Intended for use by normally healthy adults only.Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. This formulation utilizes a gel delivery system. Marketed by Kobayashi Healthcare International, Inc., this product is identified by NDC 52389-166 and is authorized under FDA application M032.

Identification & Billing

NDC Package Code
52389-166-01
Package Description
1 TUBE in 1 CARTON / 28.35 g in 1 TUBE (52389-166-28)
Product Code
52389-166
11-Digit Billing Format
52389016601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Psoriasin Gel
Non-Proprietary Name
Coal Tar Topical Gel
Substance Name
Coal Tar
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
COAL TAR 12.5 mg/g
Usage Information
Read all package directions and warnings before use.Use only as directed.Apply (gently massage in) a small amount of Psoriasin Gel to affected areas.Apply one to four times daily or as directed by a doctor.Apply to thoroughly dry skin.The active ingredient, coal tar, in Psoriasin Gel may affect very light hair color; test first on a few strands of hair before broader application to areas where light colored hair is present.Wash affected area at least daily with mild soap and warm water and dry thoroughly.Intended for use by normally healthy adults only.Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.

Regulatory & Marketing

Labeler Name
Kobayashi Healthcare International, Inc.
Product Type
Human Otc Drug
FDA Application #
M032
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-18-1996
End Marketing Date
07-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52389-166). Click a package code to view its specific billing and regulatory data.

52389-166-21
21.25 g in 1 TUBE
52389-166-42
2 TUBE in 1 BOX / 21.25 g in 1 TUBE
52389-166-43
2 TUBE in 1 BOX / 21.25 g in 1 TUBE
52389-166-56
2 TUBE in 1 CARTON / 28.35 g in 1 TUBE (52389-166-28)
52389-166-57
1 TUBE, WITH APPLICATOR in 1 CARTON / 56.7 g in 1 TUBE, WITH APPLICATOR

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52389-166-01 identifies a specific commercial package of 1 tube in 1 carton / 28.35 g in 1 tube (52389-166-28) of Psoriasin Gel, a human over the counter drug labeled by Kobayashi Healthcare International, Inc.. This gel is formulated for topical use and contains coal tar as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kobayashi Healthcare International, Inc. on February 18, 1996.

How is this Kobayashi Healthcare International, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52389016601. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
52389-166-01
11-Digit CMS (5-4-2)
52389-0166-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.